1. Field of the Invention
This invention relates to medical devices and more particularly to a method for percutaneously sealing a puncture in an artery without the need for prolonged manual pressure and without impeding blood flow within the lumen of the artery. A device is also provided to employ the sealing method.
2. Description of the Related Art
Many therapeutic procedures, especially those pertaining to the treatment of atherosclerotic coronary artery and peripheral vascular disease involve percutaneous entry into blood vessels using catheters, guide wires and other devices passed through vascular sheaths. Once the procedure is terminated and the catheters and sheaths removed, adequate hemostasis usually requires direct manual pressure over the arterial puncture site for a duration of 20 to 40 minutes, following which, the patient must remain immobile for an additional 2 to 6 hours. Patient motion during this time and/or inadequate hemostasis may result in serious bleeding complications such as hematoma or pseudoaneurysm formation, which may require surgical repair.
With the increasing utilization of outpatient catheterization procedures, aggressive anticoagulation regimens and larger intraluminal devices, an effective, simple and rapid method of arterial puncture site hemostasis would decrease hospital costs by the more efficient utilization of health care personnel and by shortening the length of hospital stay.
Conventional devices have been developed to close a puncture in a blood vessel, duct or lumen without the need to apply prolonged, direct manual pressure thereto. For example, U.S. Pat. Nos. 4,852,586; 4,890,612; and 4,744,364 to Kensey disclose hemostatic plug devices which are inserted through an arterial sheath into the lumen of the artery prior to removal of the sheath. These plug devices are then pulled back into the arterial puncture site by an attached suture to mechanically occlude the puncture site as the arterial sheath is removed. The plug devices are made of bio-absorbable material and have an enlarged head portion which, when pulled back, substantially seals the luminal surface of the puncture site. However, such devices present numerous disadvantages. There is a potential for the intraluminal head portion of the device to occlude blood flow or cause thrombosis in vessels whose luminal diameter is severely narrowed, since the plug must enter the puncture. In addition, there is a potential for the intraluminal portion of the device to embolize distally as it is bio-degraded.
European Patent Application No. 476,178A1 discloses a device for placing styptic material on perforated blood vessels. The device uses a guide wire to locate the puncture site. A dilator is pushed along the guide wire. A tube is guided along the dilator to the puncture site., The dilator and guide wire are then removed from the tube. A mechanical plug is then pushed through the tube to block the puncture site. However, since the guide wire is removed prior to inserting the plug, it cannot be assured that the plug is in a position so as to properly block the puncture site. Further, since a mechanical plug is utilized, care must be exercised when delivering the plug so that it does not enter, and thus block the vessel.
A need therefore exists to provide a method for closing a puncture in a lumen by placing a thrombogenic, hemostatic, bioabsorbable and biocompatible material on the outer surface of the wall of the lumen at the puncture site to chemically precipitate clot formation and thus, seal the puncture. A need also exists to assure that blood flow in vessels of narrow luminal diameters is not occluded by the introduction of the thrombogenic, hemostatic material.